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Bio-Path Holdings, Inc., (Nasdaq: BPTH) announced that the European Medicines Agency (EMA) granted orphan drug designation to BP1001 for the treatment of acute myeloid leukemia (AML).

“We are pleased that BP1001 has received orphan drug designation from the EMA, recognizing the urgent need for an effective treatment for AML and the potential of BP1001 to improve outcomes for patients facing this debilitating disease,” stated Peter H. Nielsen, Chief Executive Officer of Bio-Path Holdings. “This marks an important regulatory milestone for Bio-Path now that we have entered the efficacy portion of our Phase 2 trial of BP1001 for the treatment of AML.”

To receive orphan drug designation from the EMA, a therapy must be intended for the treatment of a life-threatening or chronically debilitating rare condition with a prevalence of less than five in 10,000 in the European Union. Orphan drug designation provides incentives designed to facilitate development including fee reductions for protocol assistance, scientific advice and importantly, may provide up to ten years of market exclusivity in the EU following product approval.